# K162674: BioPro Foot Plating Systems - Pathway: 510(k) (Traditional) - Applicant: Biopro, Inc. - Decided: Jun 16, 2017 after 263 days - Product code: HRS (Plate, Fixation, Bone) - Device class: 2 - Regulation: 21 CFR 888.3030 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 12 generations back to K962616 (1996). 206 ancestors in all. 19 later devices descend from it; 3 cite it directly. 0 of 226 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K072740: Mondeal Extremity Bone Fixation System, Mondeal Medical Systems GmbH (2007) Summary page 4. - K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis, Ortho Solutions Limited (2012) Summary page 4. - K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 4. - K091479: Aptus Foot System, Medartis AG (2009) Summary page 4. - K142581: APTUS Foot System, Medartis AG (2015) Summary page 4. - K140376: Variax 2 System, Stryker Trauma AG (2014) Summary page 4. - K141992: Variax 2 System, Stryker Trauma AG (2014) Summary page 4. - K090692: Ortholoc 2.0/2.4 Plate System, Wrightmedicaltechnologyinc (2009) Summary page 4. - K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 4. - K141784: Ortho Solutions Ultos Plating System, Ortho Solutions Limited (2014) Summary page 5. - K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 5. - K121651: Ortholoc 3DI Midfoot/Flatfoot System, Wrightmedicaltechnologyinc (2012) Summary page 5. - K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 4. - K120359: Ortholoc 3DI Hallux System, Wrightmedicaltechnologyinc (2012) Summary page 5. - K123000: Integra Total Foot Systems, Integra LifeSciences Corporation (2012) Summary page 5. - K110908: Aptus Foot 3.5 System, Medartis AG (2011) Summary page 5. - K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 4. - K083213: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 4. - K063672: Fibula Plate Prolock with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2007) Summary page 4. - K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates, Synthes (Usa) (2010) Summary page 4. - K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 4. - K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 5. ## Most influential descendants - K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own - K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own - K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own - K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (2019), 5 descendants of its own - K193614: FINE Osteotomy around the knee (2020), 4 descendants of its own ## Indications for use The intended use of the BioPro Foot Plating Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories: I. Forefoot System: The BioPro Forefoot Plating System is Indicated for Use in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Forefoot System is not for Spinal Use. II. Mid & Hindfoot System: The BioPro Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient. The Mid & Hindfoot System is not for Spinal Use. III. Ankle Fracture System: The BioPro Ankle Fracture System is Indicated for Use in: 1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; 2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula; 3). In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tibia and fibula in the ankle. The Ankle Fracture System is not for Spinal Use. Source page: https://510kreport.com/device/K162674 Methodology: https://510kreport.com/methodology